Overseeing compliance inspections for an investment management company. Supporting the development and maintenance of compliance processes and providing guidance on regulatory implications.
About the role
- Providing regulatory support and guidance for global and US device product registrations at ICU Medical. Assuring compliance and assisting in registration strategies and document maintenance.
Responsibilities
- Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables.
- With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers.
- Assures full regulatory compliance of all documentation for submissions and change management.
- Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
- Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
- With oversight, understand and respond to regulatory agency correspondence.
- Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
- Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
- Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
Requirements
- Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- RAC Certification preferred
- A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
- Able to assess scientific arguments and apply analytical and logical reasonings.
- Ability to effectively prioritize workload and multitask with minimal supervision.
- Good interpersonal skills.
- Good oral and written communications skills.
- Demonstrated project management skills.
- Demonstrated critical thinking, contingency planning and negotiating skills.
- Understanding of regulatory and business needs with ability to engage cross functional team members.
- Must be at least 18 years of age
Benefits
- Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
- A wide range of benefit options at affordable rates
- Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
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